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APPOSTED: 12:00 pm EST December 8, 2008
WASHINGTON -- The blockbuster asthma drug Advair does not appear to have an increased risk of serious respiratory complications seen with similar new medicines, federal health officials said Friday.
But a less widely used medication, Serevent, had a significantly higher rate of complications when compared to older treatments, the Food and Drug Administration said. Both drugs are made by the same company, GlaxoSmithKline. FDA safety reviewers are recommending that Serevent no longer be approved for treating asthma.
The FDA is concerned about asthma drugs known as LABAs, which already carry warnings. The long-acting medications relax tight muscles around stressed airways and free patients from the need to take a puff from their inhaler every few hours. For many asthma sufferers, that means they can sleep through the night.
But LABAs, for reasons that are still being debated, can increase risks of death and respiratory complications in some patients. The risk may be lower when a LABA is used together with a steroid to treat underlying inflammation deep inside the airways. Current medical guidelines suggest using both kinds of drugs together for patients with chronic asthma who are not responding well to other treatments.
Advair combines both medicines in one inhaler. But Serevent is a LABA-only product.
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